• Korean Journal of Clinical Pharmacy
• /
• v.10 no.1
• /
• pp.13-18
• /
• 2000

The bioequivalence of two clarithromycin tablets, the $Klaricid^{TM}$ (Ciba-Geigy Korea Ltd.) and the $Pylocin^{TM}$ (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers ($20\sim26$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet containing 250 mg of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector. The pharmaco-kinetic parameters (area under the concentration-time curve: $AUC_t$, maximum concentration; $C_{max}$ and time to maximum concentration; $T_{max}$) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Klaricid^{TM}$ tablet were $-0.22\%,\;-0.48\%\;and\;-1.63\%$, respectively. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;and\;T_{max}\;were\;99.07\%,\;88.15\%\;and\;99.99\%$, respectively. Detectable differences $(\Delta)\;and\;90\%$ confidence intervals ($\alpha$=0.10) were all less than $\pm20\%$ All the parameters above met the criteria of KGBT 1998, indicating that $Pylocin^{TM}$ tablet is bioequivalent to $Klaricid^{TM}$ tablet.

• The Journal of Korean Medicine
• /
• v.27 no.2 s.66
• /
• pp.36-43
• /
• 2006

Objectives : Acupuncture has been widely applied to rehabilitation after stroke by Oriental medical doctors in Korea. It has been reported that acupuncture increased cerebral blood supply and stimulated the functional activity of brain nerve cells. In addition, a correlation between activation of specific areas of brain cortices and corresponding acupuncture stimulation at the therapeutic points had been well illustrated. rill now, however, there were few studies which evaluated a correlation between activation of specific areas of brain and frequently-used acupuncture therapy for stroke, such as LI4-LI11 electro-acupuncture (EA) for paresis after stroke. This study was undertaken to evaluate the effect of LI4-LI11 EA on regional cerebral blood flow (rCBF) in normal volunteers using Single Photon Emission Computed Tomography (SPECT). Methods : In the resting state, $^{99m}Tc-ECD$ brain SPECT scans were performed on 10 normal volunteers (8 males, 2 females, mean age $25.6{\pm}2.3$years; age range from 24 to 31 years). 7 days after the resting examination, 15 minutes of electro-acupuncture were applied at LI 4 and LI 11 on the right side of the subjects. Immediately after LI4-LI11 EA, the second SPECT images were obtained in the same manner as the resting state. Significant increases and decreases of regional cerebral blood flow after LI4-LI11 EA were estimated by comparing their SPECT images with those of the resting state using paired t statistics at every voxel, which were analyzed by Statistical parametric mapping with a threshold of p=0.001, uncorrected (extent threshold: k=100 voxels). Results : EA applied at right LI4-LI11 increased rCBF in right frontopolar area (Brodmann area 10) and left middle frontal area (Brodmann area 46). Interestingly, all the areas showing increased rCBF corresponded to the territories of both anterior cerebral arteries. However, LI4-11 EA decreased rCBF in the left occipital lobe (peristriate area, Brodmann area 19). Conclusions : The results demonstrated a correlation between LI4-11 EA and rCBF increase in the frontal lobes. It is also suggested that there may be a correlation between LI meridian and the territory of the anterior cerebral arterties.

• The Journal of Korean Medicine
• /
• v.29 no.4
• /
• pp.205-212
• /
• 2008

Background and purpose: So far it was reported that acupuncture increased cerebral blood supply and stimulated the functional activity of brain nerve cells. A previous study demonstrated a correlation between LI4-11 electro-acupuncture (EA) and rCBF increase in frontal lobe. However, there remained a need to study further using various controls in acupuncture research. Transcutaneous electrical nerve stimulation (TENS) has been used as a non-invasive control in acupuncture study. This study was to evaluate the effect of LI4-LI11 TENS on regional cerebral blood flow (rCBF) in normal volunteers using single photon emission computed tomography (SPECT) and statistical parametric mapping (SPM). Methods: In the resting state, $^{99m}Tc-ECD$ brain SPECT scans were performed on 10 normal volunteers (9 males, 1 female, mean age 26.6$\pm$0.5 years; age range from 26 to 27 years). On the other day, 7 days after the resting examination, 15 minute TENS were applied at LI 4 and LI 11 on the right side of the subjects. Immediately after LI4-LI11 TENS, the second SPECT images were obtained in the same manner as the resting state. Significant increases and decreases of regional cerebral blood flow after LI4-LI11 TENS were estimated by comparing their SPECT images with those of the resting state using paired t statistics at every voxel, which were analyzed by statistical parametric mapping with a threshold of p = 0.001, uncorrected (extent threshold: k=100 voxels). Results: TENS applied at right LI4-LI11 increased rCBF in the left somatosensory association cortex (Brodmann area 5, 7). However there was no area where LI4-11 TENS decreased rCBF. Conclusion and suggestions: These results demonstrate that right LI4-LI11 TENS increased rCBF only in corresponding somatosensory association cortex, which was different from the previous results using LI4-11 EA. It is suggested that there be a different mechanism between TENS and EA.

• Tuberculosis and Respiratory Diseases
• /
• v.55 no.3
• /
• pp.250-256
• /
• 2003

Background : Anthracofibrosis, a descriptive term for multiple black pigmentation with fibrosis on bronchoscopic examination, has a close relationship with active tuberculosis (TB). However, TB activity is determined in the later stage by the TB culture results in some cases of anthracofibrosis. Therefore, it is necessary to identify early markers of TB activity in anthracofibrosis. There have been several reports investigating the serum levels of IL-2 $sR{\alpha}$, IFN-${\gamma}$ and TBGL antibody for the evaluation of TB activity. In the present study, we tried to measure the above mentioned serologic markers for the evaluation of TB activity in patients with anthracofibrosis. Methods : Anthracofibrosis was defined when there was deep pigmentation (in more than two lobar bronchi) and fibrotic stenosis of the bronchi on bronchoscopic examination. The serum of patients with anthracofibrosis was collected and stored under refrigeration before the start of anti-TB medication. The serum of healthy volunteers (N=16), patients with active TB prior to (N=22), and after (N=13), 6 month-medication was also collected and stored. Serum IL-2 $sR{\alpha}$, IFN-${\gamma}$ were measured with ELISA kit (R&D system, USA) and serum TBGL antibody was measured with TBGL EIA kit (Kyowa Inc, Japan). Results : Serum levels of IL-2 $sR{\alpha}$ in healthy volunteers, active TB patients before and after medication, and patients with anthracofibrosis were $640{\pm}174$, $1,611{\pm}2,423$, $953{\pm}562$, and $863{\pm}401$ pg/ml, respectively. The Serum IFN-${\gamma}$ levels were 0, $8.16{\pm}17.34$, $0.70{\pm}2.53$, and $2.33{\pm}6.67$ pg/ml, and TBGL antibody levels were $0.83{\pm}0.80$, $5.91{\pm}6.71$, $6.86{\pm}6.85$, and $3.22{\pm}2.59$ U/ml, respectively. The serum level of TBGL antibody was lower than of other groups (p<0.05). There was no significant difference of serum IL-2 $sR{\alpha}$ and IFN-${\gamma}$ levels among the four groups. Conclusion : The serum levels of IL-2 $sR{\alpha}$, IFN-${\gamma}$ and TBGL antibody were not useful in the evaluation of TB activity in patients with anthracofibrosis. More useful ways need to be developed for the differentiation of active TB in patients with anthracofibrosis.

• Journal of Pharmaceutical Investigation
• /
• v.38 no.4
• /
• pp.269-275
• /
• 2008

The purpose of the present study was to evaluate the bioequivalence of two levofloxacin tablets, Jeil $Cravit^{TM}$ tablet (Jeil Pharm. Co., Ltd., Korea, reference drug) and $Lesacin^{TM}$ tablet (Ilhwa. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets containing levofloxacin 200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of levofloxacin were monitored for over a period of 24 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 24 hr ($AUC_t$), maximum plasma drug concentration ($C_{max}$) and time to reach $C_{max}\;(T_{max})$ were complied from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Lesacin^{TM}$/Jeil $Cravit^{TM}$ were $\log\;0.9527{\sim}\log\;0.9981$ and $\log\;0.8712{\sim}\log\;1.0556$, respectively. These values were within the acceptable bioequivalence intervals of $\log\;0.80{\sim}\log\;1.25$, recommended by KFDA. In all of these results, we concluded that $Lesacin^{TM}$ tablet was bioequivalent to Jeil $Cravit^{TM}$ tablet, in terms of rate and extent of absorption.

• Journal of the korean academy of Pediatric Dentistry
• /
• v.43 no.4
• /
• pp.435-442
• /
• 2016

The aim of this study was to analyze physiological changes, clinical and subjective symptoms by different $N_2O$ concentrations and administration method. This study surveyed 65 men and women ages 19 to 35 and all subjects were healthy volunteers, with no contraindication for use of $N_2O$ sedation. The $N_2O$ sedation was carried out in a way that increases by 10 percent to one-minute interval or increases at once the desired level. Each method was required to reach 30 or 50 percent $N_2O$ concentration. The way to gradually raise the $N_2O$ concentration can reduce the risk by decreasing the pulse reduction rate at the same $N_2O$ concentration. $SpO_2$ has no statistical significance according to $N_2O$ concentration and method of administration. Pulse rate reduced significantly when 50% $N_2O$ increase at once during sedation and 100% $O_2$ after 5 minutes. The way to gradually raise the $N_2O$ concentration is safe for reducing pulse rate.

• Journal of Korean Foot and Ankle Society
• /
• v.16 no.2
• /
• pp.128-134
• /
• 2012

Purpose: To design novel balance tests to assess FAI and evaluate whether these tests are affected by BMI or gender, with the goal of developing reliable FAI assessment tests that are not influenced by these factors. Materials and Methods: Participants included 20 young, healthy volunteers, 12 males and 8 females, with a mean age of $24{\pm}4$ years and a mean BMI of $23{\pm}2.28$. None of the subjects had known ankle instability. The following tests were assessed in each participant: single leg balance (SLB), percentage of leg press (PLP), single leg cycling (SLC), one leg squat (OLS), multiple direction reach-front/back/side (MDR-F/B/S), single leg hop (SLH), two leg jump (TLJ) and side step (SS). Data were analyzed using the SPSS 12.0 software program with ANOVA and t-test used. Results: When grouped by BMI, we found that despite differences in BMI, the performances of all subjects were equivalent except for the one-leg-squat test, for which the mean ratios for underweight ($1.69{\pm}0$), normal weight ($1.05{\pm}0.19$), and overweight ($0.93{\pm}0.30$) individuals were significantly different (p=0.02); ratios for SLB (p=0.273), SLC (p=0.903), PLP (p=0.664), MDR-F/B/S (p=0.498, 0.908, and 0.503, respectively), SLH (p=0.332) were not significantly different. When calculated according to gender, we found that the OLS (p=0.013) and MDRS (p=0.034) were significantly different, while parameters for all the remaining tests were not affected. Conclusion: We found that the SLB, PLP, SLC, MDR-F/B, and SLH ratios were unaffected by BMI or sex and, therefore, are reliable parameters for assessing ankle instability.

• Korean Journal of Clinical Pharmacy
• /
• v.15 no.1
• /
• pp.41-45
• /
• 2005

심바스타틴은 cholesterol 생합성 과정에서 속도 조절 효소인 HMG-CoA reductase의 강력한 상경적 길항약으로서 고지혈증 치료에 널리 쓰이는 약물이다. 심바스타틴 제제인 MSD 사의 조코 20 mg정을 대조약으로 하여 시험약인 유영 제약의 엘바스타 20mg정의 생물학적 동등성 평가를 하기 위해 22명의 건강한 지원자를 모집하였다. 지원자를 두 군으로 나누어 2정씩 투여하였고 $2{\times}2$ 교차시험을 실시하였다. 심바스타틴의 혈장 중의 농도를 정량하기 위하여 발리데이션된 LC/MS/MS를 사용하였다. 채혈 시간은 투약 전 및 투약 후 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 시간에 걸쳐 총 12시점에 걸쳐 시행하였다. 생물학적 동등성을 판정하기 위한 파라미터로 12시간까지의 혈장 중 농도곡선 하 면적 ($AUC_{12hr}$)과 최고 혈중 농도($C_{max}$)를 사용하였다. 12시간 까지의 혈중 농도 곡선 하 면적의 기하 평균은 $17.30ng{\cdot}ml/hr$(시험약)과 $17.35ng{\cdot}ml/hr$(대조약)으로 나타났다. 최고 혈중 농도의 경우 각 각 5.08 ng/ml(시험약)과 5.20 ng/ml(대조약)으로 관찰 되었다. $AUC_{12hr}$의 경우 로그변환한 평균치 차의 $90{\%}$ 신뢰구간이 log0.8510 - log1.1694이었고, $C_{max}$의 경우 log0.8176 - log1.1649로 계산되어 두 항목 모두 log0.8-log1.25이어야 한다는 식품의약품 안전청과 FDA의 기준을 모두 만족시켰다. 이상의 결과를 종합하면 시험약 엘바스타 정 20mg은 대조약 조코정 20 mg에 대하여 생물학적 동등한 것으로 판정되었다.트리머 전기비저항 탐사를 수행하였다. 이를 통해 하저에 케이블을 설치하는 방식에 비해 매우 신속하고 경제적으로 하저에 분포하는 이상대의 분포범위와 발달방향을 규명할 수 있었다.대에 대해 가장 효과적이다. 모델과 현장 적용 결과들을 통해 GRM SSM 방법을 이용하여 불규칙한 굴절면을 가진 지층들에 대해 좀 더 신뢰할 수 있는 정밀한 탄성파 속도를 산출할 수 있음을 보여주고 있다.별한 주의를 기울여야 한다.EX>$\alpha/\beta$=10인 경우 $62.0\~121.9\;Gy_{10}$ (중앙값: $93.0\;Gy_{10}$)의 분포를, ${\alpha/\beta}=3$인 경우 $93.6\~187.3\;Gy_3$ (중앙값=$137.6\;Gy_3$ )의 분포를 보였다. MD-BED $Gy_3$는 직장합병증 발생과의 관계는 통계적으로 유의하였고, 방광합병증과는 유의하지 않았다. 직장합병증과의 연관성은 MD-BED $Gy_3$보다 개별 환자의 직장전벽 총 선량 BED값인 R-BED $Gy_3$가 훨씬 더 높았다. 요도카테터 풍선의 후방지점이 대변하는 방광의 총 선량 BED값인 V-BED $Gy_3$도 방광합병증과 경향성 테스트에서 통계적 유의성을 보였다. 하지만, 어떠한 방사선선량도 골반제어율과 의미 있는 상관관계를 보이지 않았다. 본 기관에서 주치의의 선호도에 따라 강내근접치료가 외부방사선치료의 중간에 시행되는 형태인 샌드위치기법과 외부방사선치료 후반부에 시행되는 순차적 기법으로 구분하였을 때, 두 방식간 치료성적 및 합병증의 차이는 없었다. 총 치료기간에 대한 분석에서는 치료기간이 길어질수록 재발 위험이 커지는 경향을 보였으나, 나이 및 병기, 종양의 크기, MD-BED $Gy_{10}$

• Korean Journal of Biological Psychiatry
• /
• v.6 no.2
• /
• pp.170-175
• /
• 1999

Until recently, the etiology of schizophrenia was generally attributed to abnormalities in dopaminergic neurotransmission. Specifically, an excess of dopaminergic activity in the mesolimbic system has been postulated to produce the positive symptoms, while decreased dopaminergic activity in the mesocortical system has been suggested to cause negative symptoms. Accordingly, we performed an association study of schizophrenia with TH gene. Three hundred and seventy four biologically unrelated schizophrenic patients meeting DSM-III-R criteria from Kangnam St. Mary's Hospital affiliated with Catholic university of Korea were recruited for our study. The 393 healthy controls were volunteers for DNA library of Kangnam St. Mary's Hospital without personal or family history of psychiatric and neurologic illness. DNA was extracted from peripheral mononuclear cells and polymorphic region was amplified by polymerase chain reaction. TH intron 1 VNTR polymorphism was typed by silver staining. The allele distributions of TH gene were not different between schizophrenics and controls. However, the frequency of allele A was significantly higher in positive group than that of negative group of schizophrenics. These findings suggest that poitive schizophrenia may be associated with allele A of TH gene.

• Journal of Pharmaceutical Investigation
• /
• v.41 no.4
• /
• pp.255-262
• /
• 2011

Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.